The ingestion of infant formula by newborn babies and other infants sometimes leads to life-threatening situations if the infant has gastroesophageal reflux (GER) caused by a weak esophageal sphincter which allows stomach contents to move back into the esophagus. GER can produce a vagal response leading to apnea or bradycardia. This problem with food being regurgitated (i.e., gastroesophageal reflux) is generally controlled by placing the infant on its stomach and on an inclined surface with the head being at a higher elevation than the torso of the infant. The elevated position of the infant's head tends to prevent regurgitation of the ingested food since the force of gravity will cause the contents of the stomach to move away from the esophageal opening and to the lower portion of the stomach. However, the inclined surface which supports the infant will allow the infant to slide sideways or downwardly unless an appropriate restraining device is used to hold the infant in the desired position.
A number of devices have been previously disclosed for dealing with the GER problem. For example, U.S. Pat. No. 4,657,005 discloses a harness arrangement in which shoulder straps and waist-encircling straps are used to hold the infant in place. The device is provided with anchor straps and anti-roll straps which are pinned to the mattress on which the device is placed or, alternatively, they are tied to nearly immovable objects which serve to restrict movement of the harness arrangement. Such means for anchoring are not entirely satisfactory because repeated pinnings to the mattress have a destructive effect on the mattress fabric over a period of time and any immovable objects to which the straps are tied may not be located in the most effective position.
Another device is disclosed in U.S. Pat. No. 4,745,926 which employs straps in conjunction with a diaper-shaped portion of the device and wherein the straps extend over the shoulders and are provided with tabs for pinning the straps to the infant's supporting mattress. The anchoring means in this design are also unsatisfactory for the same reason mentioned above, namely, the destructive effect that repeated pinnings have on the mattress fabric. Moreover, the device is somewhat cumbersome to use, it is uncomfortable for the infant and it may interfere with quick removal of an infant in an emergency. Also, the close proximity of other shoulder straps to the infant's head make the straps vulnerable to frequent soiling by vomit.
Other infant restraint devices which employ anchoring straps designed for attachment to side rails of a crib include U.S. Pat. No. 2,566,046 and U.S. Pat. No. 4,672,958 but those devices are generally restricted to use in cribs that have side rail uprights or similar structural elements to which anchoring straps can be attached.
In U.S. patent application Ser. No. 07/430,181 filed Nov. 1, 1989, an improved infant restraining device is disclosed which does not rely on pinning the device to a supporting mattress for anchoring purposes or on attaching straps to side rails. Instead, the device employs a pocket associated with one end of the restraint device that is designed to envelop snugly one end of the supporting mattress so that the device is held in a relatively fixed position. While that design is effective and easy to use, it requires a preformed pocket having an opening that is sized to accommodate one end of the mattress. The nursery settings in hospitals typically include cribs and mattresses of different sizes so that restraining devices relying on mattress-engaging pockets for anchoring purposes must be provided with pockets having sizes designed to accommodate the various sized mattresses. It is rather inconvenient and time-consuming to maintain an inventory of restraint devices sorted according to pocket size when the devices are laundered and returned to a nursery supply room prior to re-use of the devices.